Efficacy of a New Thickened Extensively Hydrolyzed Formula

Not Applicable

Completed

• Conditions: Cow's Milk Protein Hypersensitivity; Protein Allergy
• Interventions: Dietary Supplement: new extensively hydrolysed formula; Dietary Supplement: Extensively hydrolysed formula

• Registration Number: NCT01985607
• Lead Sponsor: United Pharmaceuticals

Brief Summary

Cow Milk Allergy (CMA) occurs in 2 to 5 % of all infants. Reflux, regurgitation and vomiting are well recognised symptoms of CMA. The recommended treatment of CMA is an extensive hydrolysate. The North American Society of Pediatric Gastroenterology Hepatology and Nutrition (NASPGHAN) \& the European Society of Pediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) reflux guidelines have no strict recommendations for the treatment of distressed infants with reflux, suspected of CMA. One of the preferred proposed options is to thicken an extensive hydrolysate .

This study aims at evaluating the additional value of a thickened extensive hydrolysate in children suspected of CMA and presenting with frequent regurgitation.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2013-07
• Study First Submitted: 2013-11-08
• Study First Submitted QC: 2013-11-14
• Study First Posted: 2013-11-15
• Study Completion: 2013-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-20
• Last Update Posted: 2015-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• term born infants
• Having a Vandenplas' score of regurgitation of at least 2
• With suspected diagnosis of CMA because of clinical history/symptoms (based on a Cow's Milk Protein hypersensitivity (CMPH) score of 10 or more) and/or positive Immunoglobulin E (IgE) testing, radioallergosorbent test (RAST) or skin prick test

Exclusion Criteria

• Exclusively breast fed infants
• Fed with an extensively hydrolysed formula or amino acid formula

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thickened	new extensively hydrolysed formula	-
Control	Extensively hydrolysed formula	-

Primary Outcome Measures

Name	Time	Method
Number of patient dropped out for intolerance	1 month
Vandenplas' regurgitations score	1 month

Secondary Outcome Measures

Name	Time	Method
Cow's milk protein hypersensitivity score	1 month
Growth (weight, height, head circumference)	6 months
Number of daily regurgitations	1 month

Trial Locations

Locations (5)

University Children's Hospital; 🇸🇮 Ljubljana, Slovenia

Hippocration Hospital; 🇬🇷 Thessaloniki, Greece

Pediatricians; 🇱🇧 Beirut, Lebanon

Faculty of Medicine, Kuwait university; 🇰🇼 Safat, Kuwait

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium